Lead portfolio quality strategy and regulatory risk governance for biological drug substances, reagents, and complex chemistry molecules. This full time role includes occasional travel. As a senior quality executive, you will guide lifecycle readiness from development through commercialization, post-market surveillance, and obsolescence. You will influence global, matrixed teams through governance, technical authority, and executive partnership. The scope includes quality systems, risk management, validation, and regulatory compliance. Key Responsibilities:

Own portfolio quality and compliance strategies using Quality Risk Management Escalate material quality, regulatory, and patient safety risks Oversee design controls, development risks, and quality engineering Lead change control, lifecycle governance,



and technology transfers Drive post-market improvement using complaints, audits, and inspection data Requirements:

Bachelor’s degree in engineering, life sciences, or related discipline 10+ years in quality, technical operations, development, or manufacturing Experience managing biologics, peptides, or complex product lifecycles Knowledge of risk management, validation, supplier quality, and statistics Working knowledge of ICH, Health Canada, FDA, and GMP requirements Use quality science, regulatory expertise, and risk leadership to strengthen Agilent Technologies’ regulated product portfolios.

📌 Director Quality Science Technology (Montague)
🏢 Allozymes
📍 Montague